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Titan Laboratories Pvt. Ltd.

2 to 4 years

Mahad

M. Pharma, B. Pharma,

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Position: R&D API
Company: Titan Laboratories Pvt. Ltd.
Location: Mahad
Experience Required: 2 to 4 years
Educational Qualification: M. Pharma, B. Pharma, or equivalent in Pharmaceutical Sciences, Chemistry, or related fields

Job Responsibilities

API Development and Optimization:

  • Develop and optimize synthetic routes for active pharmaceutical ingredients (APIs) to achieve desired purity, yield, and cost-effectiveness.
  • Scale up API synthesis from laboratory to pilot and commercial scale.
  • Conduct experiments to improve API quality, stability, and efficacy.

Formulation and Process Development:

  • Collaborate with formulation scientists to support the integration of APIs into final dosage forms.
  • Develop novel API formulations and optimize processes for large-scale manufacturing.
  • Conduct stability studies to ensure APIs meet regulatory standards.

Regulatory Compliance and Documentation:

  • Ensure compliance with cGMP, ICH, and regulatory requirements in API development processes.
  • Prepare and review documentation for regulatory submissions, including DMFs and batch records.
  • Assist in preparing dossiers for international regulatory submissions.

Research and Innovation:

  • Stay updated with the latest scientific advancements and industry trends in API development.
  • Implement innovative technologies and methodologies to enhance API production.
  • Conduct literature reviews and feasibility studies for new API developments.

Quality Control and Troubleshooting:

  • Support analytical and quality control teams in API testing and analysis.
  • Troubleshoot and resolve API production, quality, and performance issues.
  • Investigate deviations, perform root cause analyses, and implement corrective actions.

Collaboration and Reporting:

  • Collaborate with production, quality assurance, and regulatory affairs teams.
  • Prepare detailed research reports and progress updates.
  • Present findings and project updates to management and stakeholders.

Key Skills and Competencies

  • Strong knowledge of synthetic organic chemistry and API production processes.
  • Hands-on experience in API development, scaling up, and process optimization.
  • Familiarity with regulatory requirements (FDA, EMA, etc.) for API development.
  • Proficient in problem-solving, analysis, and troubleshooting.
  • Excellent communication and teamwork skills.

How to Apply

Interested candidates are encouraged to send their CV to shweta.m@titanpharma.com.

Titan Laboratories Hiring R&D API
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